Cervical CancerPhase 3HOSTTNCT00921635
A Study to Evaluate the Impact of Maintaining Hemoglobin Levels in Anemic Patients With Carcinoma of the Cervix
A Phase 3 study testing Blood transfusion in people with Cervical Cancer and Anemia, run by Tri-Service General Hospital (TSGH).
Trial summary
The purpose of this study is to assess the feasibility, safety and short term effects on health related quality of life, of maintaining hemoglobin from 120 to 130 g/L versus from 100 to 110 g/L, with red cell concentrate (RCC) transfusion, in women having chemo-radiation for cancer of the cervix. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Anemia
- What is being tested?
- Blood transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to May 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated cervix cancer
- FIGO stage IB2, II, IIIB, IVA
- Suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation
Who cannot join
- Hemoglobin level above 125g/L
- Lower one-third vaginal involvement
- Para-aortic lymphadenopathy
About this study
Official title: A Phase III Study to Evaluate the Impact of Maintaining Haemoglobin Levels Above 120g/L Verses Above 100g/L in Anaemic Patients With Carcinoma of the Cervix Receiving Concurrent Cisplatin and Radiation Therapy
The purpose of this study is to assess the feasibility, safety and short term effects on health related quality of life, of maintaining hemoglobin from 120 to 130 g/L versus from 100 to 110 g/L, with red cell concentrate (RCC) transfusion, in women having chemo-radiation for cancer of the cervix.
- Conditions
- Cervical Cancer, Anemia
- Being tested
- Blood transfusion
- Keywords
- Haemoglobin
- Medical subject headings
- Uterine Cervical Neoplasms, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusionProcedure or surgery
Blood transfusion to maintain hemoglobin level above 120 g/L
Blood transfusionProcedure or surgery
Blood transfusion to maintain hemoglobin level above 100 g/L
| Study group | Role | What they receive |
|---|---|---|
| Maintain hemoglobin level above 120 g/L | Experimental | Hemoglobin level from 120 g/L to 130 g/L Receives: Procedure: Blood transfusion |
| Maintain hemoglobin level above 100 g/L | Active comparator | Hemoglobin level from 100 g/L to 110 g/L Receives: Procedure: Blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startApr 2008
- Primary completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital
- Investigators
- Yee-Min Jen, Principal investigator, Randiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921635
- Sponsor's protocol ID
- ANZGOG0401
- Other IDs
- TSGHIRB095-05-044
- Acronym
- HOSTT
- Status last verified
- Jun 2009
- First submitted
- 15 Jun 2009
- Last updated
- 19 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study to Evaluate the Impact of Maintaining Haemoglobin Levels Above 120g/L Verses Above 100g/L in Anaemic Patients With Carcinoma of the Cervix Receiving Concurrent Cisplatin and Radiation Therapy
- ClinicalTrials.gov ID
- NCT00921635
- Acronym / sponsor ID
- HOSTT / ANZGOG0401
- Conditions
- Cervical Cancer, Anemia
- Keywords
- Haemoglobin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Collaborators
- National Taiwan University Hospital
- Study start
- Apr 2008
- Primary completion
- May 2011 (estimated)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the feasibility, safety and short term effects on health related quality of life, of maintaining hemoglobin from 120 to 130 g/L versus from 100 to 110 g/L, with red cell concentrate (RCC) transfusion, in women having chemo-radiation for cancer of the cervix.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintain hemoglobin level above 120 g/L | Experimental | Procedure: Blood transfusionHemoglobin level from 120 g/L to 130 g/L |
| Maintain hemoglobin level above 100 g/L | Active comparator | Procedure: Blood transfusionHemoglobin level from 100 g/L to 110 g/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previously untreated cervix cancer
- FIGO stage IB2, II, IIIB, IVA
- Suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation
Key exclusion criteria (3 listed)
- Hemoglobin level above 125g/L
- Lower one-third vaginal involvement
- Para-aortic lymphadenopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood transfusionBlood transfusion to maintain hemoglobin level above 120 g/L | Procedure or surgery | Maintain hemoglobin level above 120 g/L |
| Blood transfusionBlood transfusion to maintain hemoglobin level above 100 g/L | Procedure or surgery | Maintain hemoglobin level above 100 g/L |
Primary outcome
The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yee-Min Jen principal investigator
Randiation Oncology
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blood transfusion in people with Cervical Cancer and Anemia, run by Tri-Service General Hospital (TSGH).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 19 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2009.